TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS 8000 UNIVERSAL ROLLER
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Model Number 16402 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The field service representative (fsr) verified that one of the rollers on the pump was loose and not holding occlusion.She was unable to tighten the inner screw on the roller.The roller cap was spinning freely with the rest of the roller and could not be unscrewed from the roller base.As a result, the roller pump was replaced.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the cardioplegia pump was not holding occlusion.The occlusion was set correctly but it was lost after a few pump rotations.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician observed that when the roller pump was running overnight it had unscrewed itself, creating a pump jam error.It was found that the gut assembly was the cause of the problem.
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Event Description
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Per clinical review: on 25-feb-2020, the team placed the 4:1 cardioplegia (cpg) roller pump was placed in the roller head, primed, occlusion set as normal, per protocol for the procedure.Shortly after commencing cardiopulmonary bypass, it was noticed that the roller pump would not hold occlusion, they tightened the occluded knob, and it would still not hold the occlusion appropriately to deliver the correct cpg amount.The team then decided to move the disposable set to an open roller pump, and had no concern the remainder of the procedure.There was no harm or blood loss associated with the event.The incident did not delay the continuation of the surgical procedure.
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Manufacturer Narrative
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The reported complaint was confirmed.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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